Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While George Annas has praised law and rights-talk for creating modern bioethics, Carl Schneider has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one account, typified by Albert Jonsen, bioethics largely grew out of philosophy and theology, not law. In another account, law has deeply shaped bioethics from the start, forging its central commitment to the rights of patients and research subjects and the fields imposition of broad fiduciary responsibilities on health care professionals and researchers.

In addition to debating how to properly describe laws historical relationship to bioethics, commentators have argued over whether laws influence in bioethics is now good or bad.

Critics of the gaps in our nation’s health insurance decry the absence of a health insurance “system” and the resulting “patchwork” of private and public insurance that leaves so many Americans unprotected. There is no question that these gaps are unconscionable; but they are also no accident. They are the result of policy and political choices with substantial consequences for those who remain uncovered. In my view, (based on experience as well as the excellent scholarship of others) the fundamental political barrier to universal coverage is that our success in insuring most of the nation’s population has “crowded out” our political capacity to insure the rest. This paper will explain how we arrived at the mix of private and public insurance we now have, how that mix impedes efforts to achieve universal coverage, and how “crowd-out” affects strategy for improving coverage in the future.

Many new genetic tests are used in clinical practice, and the number of available tests is growing. Two important health policy questions arise as these genetic tests become available. The first question, whether a new test should be made available, has been the focus of much recent discussion. The second question concerns defining the appropriate standards surrounding the use of these tests, including patient selection, education, informed consent, test interpretation and counseling.

Genetic tests currently move from the research arena, where strategies are put in place to minimize risks,into the clinical context where the practice of medicine is more variable and the risks to patients less understood. In the research setting, risks can be minimized through safeguards including education, consent, and counseling. The frequency and magnitude of psychosocial and clinical risks canbe assessed. In the clinical setting, however, these safeguards may not be used consistently, creating unknown risksfor patients (see table).

For more than two decades, significant controversies have been brewing over the efficacy and safety of Selective Serotonin Reuptake Inhibitors (or SSRIs) and other treatments for depression, and also over the expansion of their use for the treatment of a variety of other conditions. These controversies culminated, in June 2004, with alawsuit intended by Eliot Spitzer, Attorney General of the State of New York. The lawsuit accused pharmaceutical giant GlaxoSmith-Kline of “repeated and persistent fraud by misrepresentation, concealing and otherwise failing to disclose to physicians information in its control concerning the safety and effectiveness of its antidepressant medication paroxetine” (better known as “Paxil”) in treating children and adolescents suffering from depression.

Despite a consensus across the political spectrum that the problem of the chronically uninsured is in dire need of solution, little progress has heen made. Public spending goes to topping up coverage for the elderly, already heavily subsidized under Medicare, or helping people temporarily without insurance because of international trade dislocations, so that it is clear that something is lacking in the case for significantly reducing the number of uninsured persons. In this paper I suggest that there have been two missing ingredients: a strategy for breaking the political deadlock around this issue, and information about the benefits of coverage sufficient to persuade kindly but skeptical taxpayers that they should be willing to pay to help solve this problem.

This article begins with a discussion of these two problems. It then outlines a strategy based on income-related or conditioned refundable tax credits for private and public insurance, coupled with a plan to assemble persuasive information that may move things forward.

In his compelling novel Blindness, José Saramago tells us about victims stricken by a contagious form of blindness who were quarantined and came to see themselves as pigs, dogs, and “lame crabs.” Of course, they were all human beings - although unable to perceive themselves, or others, as members of the human community. The disciplines of bioethics, health law, and human rights are likewise all members of the broad human rights community, although at times none of them may be able to see the homologies, even when responding to a specific health challenge.

The boundaries between bioethics, health law, and human rights are permeable, and border crossings, including crossings by blind practitioners, are common. Two working hypotheses form the intellectual framework of this article: we can more effectively address the major health issues of our day if we harmonize all three disciplines; and American bioethics can be reborn as a global force by accepting its Nuremberg roots and actively engaging in a health and human rights agenda.

In August 2001,just after President Bush announced his stem cell funding policy and the creation of a new Presidents Council on Bioethics PCB), the new chair of the PCB, Leon Kass, set out his philosophy for constructing public bioethics bodies: There are several ways of running commissions, he said. One is to stack it with your people, make them homogenous, and force a consensus. Another is to make them heterogeneous, so that you can only come to the lowest common denominator. We re not going to adopt either . We are going to allow the debate to be developed and heard.

Now, three years, sixteen meetings, and five reports later, there are nagging questions about whether this council indeed has allowed the debate to be developed and heard. And the charge of politicizing public bioethics to a degree heretofore unknown and stifling the voices of dissenting members comes not from the political left but from President Bushs own appointees, including one scientist who was dismissed from further service.

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.

In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs.

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia.

For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.

Xenotransplantation is any transplantation, implantation, or infusion of either live cells, tissues, or organs from a nonhuman animal source, or human bodily fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs into a human recipient. Most scientists agree that clinical xenotransplantation should not be performed in the absence of accompanying public health safeguards The science upon which that consensus is based has been extensively described in the literature. By and large the most compelling reason for public health safeguards is the possible introduction of new infectious agents into the human life cycle as a result of xenotransplantation.

The most frequent source of new infectious diseases in human populations is the transfer of agents, such as viruses, bacteria, or prions, from animals to man. Human diseases and infectious agents that are thought to have originated from animals include influenza, rabies, malaria, lassa fever, lyme disease, AIDS, yellow fever, tuberculosis, the human t-cell lymphotropic virus, the herpes B virus, the hantavirus, and even the bubonic and pneumonic plagues.

Modern bioethics, which is based on Western moral philosophy and Western biomedical perspectives, has evolved within a complex, highly individualistic culture that draws a sharp distinction between church and state and tolerates a multitude of values. This discipline defines its principles in secular and objective terms that often are bewildering to people of non-Western origin. Despite much discourse, principlism remains the fundamental framework of bioethics. Principlism is held in such high regard that many bioethicists equate autonomy with personhood, as if autonomy exists independently of specific beliefs and commitments.

In addition, we continue to minimize the substantial differences in the way people of different cultures perceive, experience, and explain illness, although our views of the potential cultural limitations of Western medicine have grown and expanded in recent years. At the heart of it we continue to be tied to a biomedical focus that largely neglects the context of the situation.

Back injuries have a bad reputation. The workman looks upon them with apprehension, the insurance company with doubt, the medical examiner with suspicion, the lawyer with uncertainty. The medical examiner is faced with the difficulty of estimating the true value of the subjective symptoms in the comparative absence of physical signs. His suspicion is born of the frequent disparity between these two.

This prophetic statement made almost 100 years ago highlights an ongoing problem - how people who are incapacitated by painful conditions such as chronic low back pain can be evaluated consistently and equitably for purposes of disability compensation. We confronted this vexing problem when we participated in writing the chapter devoted to impairment associated with pain (Chapter 18) of the American Medical Association s Guides to the Evaluation of Permanent Impairment, 5th edition AMA Guides 5th Our purposes in this essay are to clarify several important conceptual issues associated with the assessment of pain among disability applicants, and to articulate reasons why pain should be considered in impairment and disability ratings.

Male to male unprotected anal sex is the main route of HIV transmission in Australia. The Australian Study of Health and Relationships, a large, representative population survey of sexual health behaviors, found that six percent of males in the general population have engaged in homosexual activity. These findings were consistent with studies in Europeand North America. Condoms have been shown to reduce the transmission of HIV in the community. Barriers to the use of condoms include access,stigma,and cost? Nevertheless, increased condom use has been reported among homosexual males, sex workers and injecting drug users although recent declines in condom use among homosexuals has presented new challenges in HIV prevention.

The prevalence of male to male sexual activity may be higher in prison than in the general population. Sexual activity in prison can be consensual and non-consensual involving both homosexual / bisexual and heterosexual men.

Protecting the privacy of individually-identifiable health data is a dominant health policy objective in the new millennium. Technological, economic, and health-related reasons substantiate the development of a national electronic health information infrastructure. Through this emerging infrastructure, billions of pieces of health data of varying sensitivities are exchanged annually to provide health care services and service transactions, conduct health research, and promote the public’s health. These multi-purpose, rapid exchanges of electronic health data, far removed from the typical disclosure of health information through the doctor/patient relationship of yesteryear, contribute to heightened individual concerns about identifiable health data. Responding to American fears and perceptions of actual and potential privacy abuses, policymakers have recently developed new, modern privacy protections through legislative and regulatory laws, as well as ethical and industry codes.

Modern health information privacy protections are reflected in federal regulations developed by the federal Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Criminal law and the proceedings surrounding it work, at least in theory, much like an author works when writing a play or a novel. Both the lawyer and the writer follow traditional formulae that allow them to create and express a vision of reality. When done well, the reality created is virtually seamless. This, however, is the point at which law and literary works diverge. Although we embrace creativity in literary endeavors, we would prefer that the foundation of our legal system be something more substantial. Unfortunately, where US. criminal HIV exposure statutes are concerned, there appears to be little if any concrete connection between proscribed behaviors and what we know about HIV transmission risk. Twenty-four states in the U.S. make it a criminal offense for a person who has HIV to expose another to the virus through consensual sexual activities. The relationship between the activities prohibited by these laws and actual risk of virus transmission is tenuous at best.